The antibody cocktail comprises casirivimab and imdevimab and leverages Regeneron's VelocImmune and VelociSuite technologies
Regeneron headquarters under construction. (Credit: Jim.henderson/Wikipedia.)
The Medicines and Healthcare products Regulatory Agency (MHRA) of the UK has granted Conditional Marketing Authorisation (CMA) for the antibody cocktail developed by Regeneron and Roche, to prevent and treat Covid-19.
The cocktail comprises monoclonal antibodies casirivimab and imdevimab and leverages Regeneron’s VelocImmune and VelociSuite technologies.
It is called REGEN-COV in the US and Ronapreve in the UK and other countries.
The drug is administered either by injection or infusion, where it binds tightly to the coronavirus and prevents it from attaching to the cells of the respiratory system.
Regeneron and Roche have initially collaborated in August last year to jointly develop, manufacture and distribute Regeneron’s investigational antiviral antibody combination.
Regeneron president and chief scientific officer George D Yancopoulos said: “Despite the remarkable collective efforts of governments, healthcare professionals and communities across the globe, Covid-19 continues to cause significant illness and death, with new variants making the fight even more challenging.
“In addition to preventing hospitalisation and death in patients already infected with the virus, we are encouraged that governments recognize the benefits of REGEN-COV in preventing infection in the first place, including in immunocompromised people who may not respond to vaccines due to an underlying medical condition, or medicines used to treat an underlying condition.
“This indication is now authorised in the UK and available under early access authorisation in France, and we are in ongoing discussions with other regulatory authorities, including the US FDA, to help bring REGEN-COV prevention to the many at-risk immunocompromised individuals who are not sufficiently protected by vaccination.”
MHRA approved Ronapreve as the first monoclonal antibody combination product indicated for use in the prevention and treatment of acute Covid-19 infection for the UK.
The approval in the UK follows the emergency use authorisation (EUA) granted by the US Food and Drug Administration (FDA) earlier this month.
The approval of Ronapreve was based on results from two Phase 3 trials, and a recommendation by the Commission on Human Medicines (CHM).
According to the clinical trial data, Ronapreve may prevent infection, reduces symptoms of acute Covid-19 infection and reduces the chances for hospitalisation due to Covid-19.
UK Health and Social Care Secretary Sajid Javid said: “The UK is considered a world leader in identifying and rolling out life-saving treatments for Covid-19, once they have been proven safe and effective in our government-backed clinical trials.
“This is fantastic news from the independent medicines regulator and means the UK has approved its first therapeutic designed specifically for Covid-19.
“This treatment will be a significant addition to our armoury to tackle Covid-19 – in addition to our world-renowned vaccination programme and life-saving therapeutics dexamethasone and tocilizumab.
“We are now working at pace with the NHS and expert clinicians to ensure this treatment can be rolled out to NHS patients as soon as possible.”